Abstract

SESSION TITLE: COPD Posters V

SESSION TYPE: Original Investigation Poster

PRESENTED ON: Wednesday, October 28, 2015 at 01:30 PM - 02:30 PM

PURPOSE: Dyspnea is a critical symptom of COPD and a major cause of the disease-associated disability. Dual bronchodilation therapy is recommended by the GOLD 2015 strategy, if symptoms are not adequately managed by a single bronchodilator. QVA149 (110/50 µg) is an inhaled fixed-dose combination of indacaterol (IND) and glycopyrronium (GLY), approved in over 50 countries including EU, Japan, Canada, Mexico, Australia and Switzerland for the maintenance treatment of COPD. Here, we report the effect of QVA149 (IND/GLY) on dyspnea versus its monocomponents and placebo from the pooled analysis of the FLIGHT1 and FLIGHT2 studies.

METHODS: FLIGHT1 and FLIGHT2 were replicate, 12-week, multicenter, double-blind studies that randomized (1:1:1:1) patients with moderate-to-severe COPD to IND/GLY (27.5/12.5 µg b.i.d.), IND (27.5 µg b.i.d.), GLY (12.5 µg b.i.d.) and placebo. Data on Transition Dyspnea Index (TDI) total score at Week 12 were pooled from these studies. The percentage of patients that achieved minimal clinically important difference (MCID) in TDI total score was also reported.

CONCLUSIONS: In this pooled analysis, IND/GLY provided statistically significant improvement in dyspnea, as measured by TDI total score versus placebo and its monocomponents in patients with moderate-to-severe COPD. Also, the proportion of patients achieving MCID was significantly higher with IND/GLY compared with placebo and monocomponents.

CLINICAL IMPLICATIONS: These findings support the use of IND/GLY in relieving dyspnea in patients with moderate‑to‑severe COPD.

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